TGA / PMDA / NMPA · Asia-Pacific
efgartigimod alfa — TGA / PMDA / NMPA regulatory status
efgartigimod alfa (VYVGART) regulatory status in the Asia-Pacific is tracked from public TGA / PMDA / NMPA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: PMDA approved.
Status snapshot
- Status
- PMDA approved
- Brand
- VYVGART
- Mechanism
- IgG receptor FcRn large subunit p51 antagonist
- Target
- IgG receptor FcRn large subunit p51
- Structured fields
- 6
Pharmacology context used for competitive intelligence: IgG receptor FcRn large subunit p51 antagonist. Target: IgG receptor FcRn large subunit p51. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — PMDA: approved.
Linked evidence on this spoke: 24 published clinical programs and 0 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| PMDA | Japan | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| ARGX-113 | Phase 3 | Argenx | 2024-513147-90-00 |
| ARGX-113 | Phase 3 | Argenx | 2024-511504-17-00 |
| ARGX-113-2007 | Phase 3 | Argenx | 2024-512785-33-00 |
| ARGX-113-2008 | Phase 3 | Argenx | 2023-507379-23-00 |
| ARGX-113-2306 | Phase 3 | Argenx | 2024-516609-22-00 |
| ARGX-113-2308 | Phase 3 | Argenx | 2024-511796-15-00 |
| ARGX-113-2309 | Phase 3 | Argenx | 2023-509198-22-00 |
| ARGX-113-2315 | Phase 3 | Argenx | 2024-514133-38-00 |
| ARGX-113-2402 | Phase 3 | Argenx | 2024-515451-38-00 |
| EFGARTIGIMOD ALFA, JNJ-80202135 | Phase 3 | Janssen-Cilag International N.V | 2025-521130-28-00 |
| Efgartigimod PH20 SC | Phase 3 | Argenx | NCT06684847 |
| Efgartigimod, Placebo for efgartigimod | Phase 3 | Argenx | 2023-509197-35-00 |
Related hubs
FAQ
What is the TGA / PMDA / NMPA approval status of efgartigimod alfa?
efgartigimod alfa currently shows PMDA approved in our Asia-Pacific regulatory index. Confirm on the official TGA / PMDA / NMPA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get efgartigimod alfa regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to efgartigimod alfa?
This spoke lists 24 published programs associated with efgartigimod alfa in our pipeline index.